Abstract
<p>ABSTRACT<br />Objective: A simple and accurate stability indicating reversed-phase high-performance liquid chromatography method was developed and validated<br />for the simultaneous estimation of phenylephrine and fexofenadine in pharmaceutical dosage forms.<br />Methods: Chromatography was carried out on an ODS C-18 column (4.6 mm×250 mm, 5 µ particle size) with a isocratic mobile phase composed of<br />orthophosphoric acid buffer, acetonitrile, (75:25% v/v) at a flow rate of 1 mL/minutes. The column temperature was maintained at 30°C and the<br />detection was carried out using a photodiode array detector at 210 nm.<br />Results: The retention times for phenylephrine and fexofenadine were 2.096 minutes and 4.241 minutes, respectively. The percentage recoveries<br />of phenylephrine and fexofenadine were 100.63% and 99.84%, respectively. The relative standard deviation for assay of tablets was found to be<br />&lt;2%. The detection and quantification limits were found to be 0.10 and 0.31 µg/mL for phenylephrine and 0.01 and 0.03 µg/mL for fexofenadine,<br />respectively.<br />Conclusion: Thus, the method was fast, accurate, precise, and sensitive; hence, it can be employed for routine quality control of tablets containing<br />both drugs in quality control laboratories and pharmaceutical industries.<br />Keywords: Phenylephrine, Fexofenadine, Stability indicating method, Validation method, Reversed-phase high performance liquid chromatography.</p>
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